Provide a complete reference list for all information disseminated in the response

DisputednoteFDA guidance · non-bindingRaised as a question — a person decides

Rule

FDA recommends that information distributed in response to an unsolicited request be accompanied by a complete list of references for all of the information disseminated in the response, such as a bibliography of publications in peer-reviewed medical journals or medical or scientific texts, and citations for data on file, summary documents, or abstracts.

Check

Check that the response includes an accompanying bibliography or reference list, and assess whether every substantive claim or data point disseminated in the response has a corresponding reference in that list.

Escalate when

Escalate when it is unclear whether the reference list covers every substantive claim in the response, or whether an omitted reference is a meaningful gap in completeness.

Where this comes from

Section V, Recommendation 6 · page 12. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

This rule is one item of a list. The list is introduced by: Information distributed in response to an unsolicited request should be accompanied by the following:

…on sheet) \ A prominent statement notifying the recipient that FDA has not approved or cleared the product as safe and effective for the use addressed in the materials provided \ A prominent statement disclosing the indication(s) for which FDA has approved or cleared the product \ A prominent statement providing all important safety information including, if applicable, any boxed warning for the product \ A complete list of references for all of the information disseminated in the response (e.g., a bibliography of publications in peer-reviewed medical journals or in medical or scientific texts; citations for data on file, for summary documents, or for abstracts) 7. A firm should maintain the following records: \ The nature of the request for information, including the name, address, and affiliation of the requestor \ Records regarding the information provided to the requestor \ Any follow-up inquiries or questions from the requestor If a firm responds to non-public unsolicited requests for off-label information in the manner described above, FDA does not intend to…

Open the original at page 12 on fda.gov ↗Read our full copy →

Document: FDA guidance: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (see document)
Version: as retrieved — the publisher does not version this document; the fingerprint below identifies the exact file
Retrieved: 2026-09-21 from www.fda.gov
Fingerprint: 8ab6bfda34ad39a70987805b…

FDA guidance describes the agency's current thinking. It is not binding law, and this rule is a recommendation, not an obligation.

Applies when

Basisunsolicited-request

How this rule was checked

The verifier and drafter could not agree. Waiting for a human decision — not used in reviews.

Drafted
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The substance is supported: the fifth bullet under Section V Recommendation 6 (lines 312-314) lists 'A complete list of references for all of the information disseminated in the response'.
- The quote is a bare noun phrase lifted from a bulleted list; standing alone it has no subject or verb and does not read as a recommendation at all. The obligation lives in the stem at lines 300-301 ('Information distributed in response to an unsolicited request should be accompanied by the following:'), which the quote drops.
- Determinism is mislabelled. Presence of a bibliography is deterministic, but the rule and its check are about *completeness* — 'every substantive claim or data point ... has a corresponding reference' — which turns on adequacy and requires judgment about what counts as substantive and as adequately referenced.
- Authority 'guidance' and severity 'note' are defensible; the locator (Section V, Recommendation 6) is correct.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is only the lead-in to Recommendation 6 ('Information distributed in response to an unsolicited request should be accompanied by the following:'). It says nothing about references. The reference-list requirement the rule states comes from a later bullet ('A complete list of references for all of the information disseminated in the response ...') that the quote leaves out. As quoted, the text does not establish this rule.
- The rule text itself is a faithful 'FDA recommends' restatement of that bullet, so this is fixable by requoting. The bullet cannot be quoted alone, because it is a subjectless list item that needs the lead-in.
- A reference list's presence is a literal check, but whether it covers every item disseminated is a judgment call, so 'judgment' is correct. The locator is correct.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The rule text faithfully restates the fifth bullet of Section V Recommendation 6 as an FDA recommendation.
- The quote is a bare list item ('A complete list of references...') with no lead_in; the recommendation is only in the non-adjacent lead-in sentence.
- The title 'Provide a complete reference list for all information disseminated in the response' is a bare command for a guidance recommendation.
- Section V applies to private responses to non-public unsolicited off-label requests; the rule text does not carry that limit.
- Judgment is correct because completeness of coverage is an assessment; severity 'note' is defensible.
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- Quote plus lead_in from Section V, Recommendation 6 supports the recommendation of a complete reference list for all information disseminated; rule body correctly phrases it as 'FDA recommends'.
- Judgment determinism is correct: completeness of coverage of every disseminated item requires judgment. Note severity is defensible.
- The title 'Provide a complete reference list for all information disseminated in the response' is a bare command derived from a non-binding 'should'.
- Locator 'Section V, Recommendation 6' is less specific than sibling rules but acceptable.